The medical device trade group tells FDA which guidance topics should be tackled first.
The Advanced Medical Technology Association (AdvaMed) has voiced its opinion on which topics the medtech industry believes should be FDA’s highest priorities.
In early January, FDA’s Centers for Device and Radiological Health (CDRH) released its Fiscal Year 2015 Proposed Guidance Development. This set out a prioritized list of topics for which CDRH may issue draft and final guidance documents in FY15. The topics are broken down into two lists–the A-list and the B-list. CDRH intends to publish guidance on A-list topics in FY15, while guidance on B-list topics will be published “as…resources permit.” The window for comments on the proposal closed earlier this month.
In a comment posted last week, AdvaMed sounded off on the CDRH list, giving the agency its own take on which topics are most important. This meant the trade group would like to see some of the A-list topics reshuffled according to priority, some B-list topics moved to the A-list grouping and vice versa, as well as a few new topics added…
The trade group also wants to see several guidance documents updated, including guidance on “Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software” and “Pilot Program to Evaluate a Proposed Globablly Harmonized Alternative for Premarket Procedures.”
FDA has already made progress on its list since the comment period closed earlier this month. On March 12, FDA released its finalized guidance on medical device reprocessing in the health care setting.
The agency does not get to all of the A-list topics each year. Some topics such as “Applying Human Factors and Usability Engineering to Optimize Medical Device Design” have been carried over from the FY14 priority list and made AdvaMed’s FY14 high priority list as well.